Summary
This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.
Conditions
Cardiac Arrest, Out-Of-Hospital, Hypothermia, Induced, Hypoxia-Ischemia, Brain
Recruitment Status
Recruiting
Eligibility Criteria
Inclusion criteria:
Age 2 days to < 18 years with corrected gestational age of at least 38 weeks
Chest compressions for at least 2 minutes
Coma or encephalopathy after resuscitation from Out-of-Hospital Cardiac Arrest (OHCA)
Requires continuous mechanical ventilation through endotracheal tube or tracheostomy
Definitive temperature control device initiated
Randomization within 6 hours of Return of Spontaneous Circulation (ROSC)
Informed consent from Legally Authorized Representative (LAR) including intent to maintain life support for 120 hours
Exclusion criteria:
Glasgow Coma Motor Score (GCMS) = 6
LAR does not speak English or Spanish
Duration of Cardiopulmonary Resuscitation (CPR) > 60 minutes
Severe hemodynamic instability with continuous infusion of epinephrine or norepinephrine of 2 micrograms per kilogram per minute (μg/kg/minute) or initiation of Extracorporeal membrane oxygenation (ECMO)
Pre-existing severe neurodevelopmental deficits with Pediatric Cerebral Performance Category (PCPC) =5 or progressive degenerative encephalopathy
Pre-existing terminal illness, unlikely to survive to one year
Cardiac arrest associated with brain, thoracic, or abdominal trauma
Active and refractory severe bleeding prior to randomization
Extensive burns or skin lesions incompatible with surface cooling
Planned early withdrawal of life support before 120 hours
Sickle cell anemia
Pre-existing cryoglobulinemia
Non-fatal drowning in ice covered water
Central nervous system tumor with ongoing chemotherapy
Previous enrollment in P-ICECAP trial
Prisoner
Chronic hypothermia
New post-cardiac arrest diabetes insipidus
Pregnancy
Intervention
Intervention Type
Intervention Name
Device
Therapeutic Hypothermia
Phase
Not Applicable
Gender
All
Min Age
2 Days
Max Age
17 Years
Download Date
March 29, 2024
Principal Investigator
Sarah Murphy, MD
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
Primary Contact Information
samurphy@mgh.harvard.edu
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: